Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mini Lap Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
338 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101101 | MINI-TONG | Mini Lap Technologies, Inc. | 2010-07-23 | 94 | 0 |
| K093449 | MINI LAP RETRACTORS | Mini Lap Technologies, Inc. | 2010-02-12 | 99 | 0 |
| K083754 | MINI LAP ELECTROCAUTERY INSTRUMENTS | Mini Lap Technologies, Inc. | 2009-11-20 | 338 | 0 |
| K070686 | MINI LAP INSTRUMENTS | Mini Lap Technologies, Inc. | 2007-04-05 | 24 | 0 |
| K070352 | MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM | Mini Lap Technologies, Inc. | 2007-04-05 | 58 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda